Preemptive Mavyret Therapy for Hepatitis C in Organ Transplant Recipients

Recruiting at 1 trial location

Overseen By Rolland Dickson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Chronic liver disease, HIV, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if using two medicines together can stop Hepatitis C from spreading to people who get an organ transplant from a donor with Hepatitis C. The goal is to protect the new organ recipient from getting infected by the virus.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Mavyret generally safe for humans?

The research articles provided do not contain specific safety data for Mavyret or its use in organ transplant recipients. However, they do mention safety profiles for other medications, such as telaprevir, which had side effects like rash, anemia (low red blood cell count), and nausea, and dolasetron, which was well tolerated even in patients with liver issues. ^{1 2 3 4 5}

How is the drug Mavyret unique for treating hepatitis C in organ transplant recipients?

Mavyret is unique because it is an all-oral regimen that combines two direct-acting antiviral agents, glecaprevir and pibrentasvir, which target different stages of the hepatitis C virus lifecycle, offering a shorter treatment duration and fewer side effects compared to older therapies like interferon and ribavirin. ^{6 7 8 9 10}

Research Team

Bashar A Aqel

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for kidney, heart, lung, or pancreas transplant patients without chronic hepatitis C. Participants must be willing to accept a graft from a donor with hepatitis C and understand the risks of acquiring HCV infection. Those with chronic liver disease, pregnant women, or individuals with HIV or chronic hepatitis B cannot join.

Inclusion Criteria

Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection

Willing to accept and consent for accepting hepatitis C positive graft

Exclusion Criteria

Existing chronic liver disease (liver cirrhosis)

Pregnancy (Pregnant patients do not undergo solid organ transplants)

You or someone taking care of you do not understand or accept the risk of getting Hepatitis C during the course of the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-emptive Treatment

Participants receive combination therapy with Glecaprevir/pibrentasvir (G/P) and Ezetimibe to prevent HCV transmission

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including graft and patient survival

1 year

Treatment Details

Interventions

• Mavyret

Trial Overview The study tests the effectiveness of Mavyret in preventing the transmission of Hepatitis C from an infected donor to a recipient who does not have Hepatitis C during organ transplantation.

Participant Groups

Group I: Arm 1: Pre-emptive Treatment Arm Experimental Treatment 1 Intervention

Single arm study were all recipients of HCV viremic organs will receive combination therapy.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The combination of netupitant and palonosetron is effective in preventing both acute and delayed nausea and vomiting caused by moderately and highly emetogenic chemotherapy, as supported by phase II and III clinical trials.

This treatment offers a convenient single-capsule dosage and has a favorable side effect profile, although its high cost and administration logistics may pose challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of netupitant and palonosetron in chemotherapy-induced nausea and vomiting. Abramovitz, RB., Gaertner, KM.[2018]

A total of 228 adverse drug reaction reports were analyzed for nirmatrelvir/ritonavir (Paxlovid®) in France, with serious reports making up 40% of the cases, highlighting the importance of monitoring its safety profile, especially in older patients (mean age 66).

Drug-drug interactions (DDIs) were a significant concern, accounting for over 13% of reports, primarily involving immunosuppressive drugs, and the main unexpected adverse reactions included high blood pressure, confusion, acute kidney injuries, and skin reactions, necessitating careful management in patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nirmatrelvir/ritonavir (Paxlovid®): French pharmacovigilance survey 2022. Bihan, K., Lipszyc, L., Lemaitre, F., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The role of netupitant and palonosetron in chemotherapy-induced nausea and vomiting. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of dolasetron after oral and intravenous administration of dolasetron mesylate in healthy volunteers and patients with hepatic dysfunction. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Nirmatrelvir/ritonavir (Paxlovid®): French pharmacovigilance survey 2022. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Telaprevir user's guide. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Real-world evidence of NEPA, netupitant-palonosetron, in chemotherapy-induced nausea and vomiting prevention: effects on quality of life. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of new treatment options for hepatitis C virus infection in liver transplantation. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Applicability, tolerability and efficacy of preemptive antiviral therapy in hepatitis C-infected patients undergoing liver transplantation. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Section 13. Short-course pretransplant antiviral therapy is a feasible and effective strategy to prevent hepatitis C recurrence after liver transplantation in genotype 2 patients. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Antiviral therapy for hepatitis C in the setting of liver transplantation. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Pre-emptive antiviral therapy in living donor liver transplantation for hepatitis C: observation based on a single-center experience. [2018]